BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC TI LOW PROFILE SCREW 6.5X60MM

    MDR report key: 19462070 · Received June 4, 2024

    Report

    Report Number
    0001825034-2024-01475
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Date of Event
    May 2, 2024
    Report Date
    November 18, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304004061
    PMA / PMN Number
    K082446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, G3, G6, H2, H3, H6, H10, AND H11. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 MEDICAL DEVICES: BIOMET POR PRI TIBIAL TRAY 83MM CATALOG#: 141266 LOT#: 66218613 RINGLOC TITANIUM LOW PROFILE SCREW 6.5X60MM CATALOG#: 103538 LOT#: 446260 CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE BONE SCREWS WOULD NOT GO THROUGH THE TIBIAL TRAY AND SEAT IT TO THE BONE. THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL TIBIAL TRAY AND SCREWS THAT WERE AVAILABLE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173857 RINGLOC TI LOW PROFILE SCREW 6.5X60MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 446260 00880304004061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male SEE H11